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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K151359
Device Name ROSA Brain
Applicant
MEDTECH S.A.
ZAC EUREKA - 900 RUE DU MAS DE VERCHANT
MONTPELLIER,  FR 34000
Applicant Contact MICHAEL CHRIST
Correspondent
MED TECH S.A.
ZAC EUREKA - 900 RUE DU MAS DE VERCHANT
MONTPELLIER,  FR 34000
Correspondent Contact Elise Lagacherie
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/20/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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